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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Dialysate Sack (SAK) with Concentrate - M535SAK3040

No Description
NXSTAGE MEDICAL, INC.
SAK-304
In Commercial Distribution

  • M535SAK3045 ()
  • M535SAK3040 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK303A0

No Description
NXSTAGE MEDICAL, INC.
SAK-303-A
In Commercial Distribution

  • M535SAK303A5 ()
  • M535SAK303A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3030

No Description
NXSTAGE MEDICAL, INC.
SAK-303
In Commercial Distribution

  • M535SAK3035 ()
  • M535SAK3030 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK302A0

No Description
NXSTAGE MEDICAL, INC.
SAK-302-A
In Commercial Distribution

  • M535SAK302A5 ()
  • M535SAK302A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3020

No Description
NXSTAGE MEDICAL, INC.
SAK-302
In Commercial Distribution

  • M535SAK3025 ()
  • M535SAK3020 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK301A0

No Description
NXSTAGE MEDICAL, INC.
SAK-301-A
In Commercial Distribution

  • M535SAK301A5 ()
  • M535SAK301A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3010

No Description
NXSTAGE MEDICAL, INC.
SAK-301
In Commercial Distribution

  • M535SAK3015 ()
  • M535SAK3010 ()


  • Haemodialysis concentrate

NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP - M535CAR5350

No Description
NXSTAGE MEDICAL, INC.
CAR-535
In Commercial Distribution

  • M535CAR5355 ()
  • M535CAR5350 ()


  • Haemodialysis/haemofiltration system component set

FRYDMAN ® SOFT WITH GUIDE - 03700111400047

03 pieces sets for embryo transfer
LABORATOIRE CCD
FRYDMAN ® SOFT WITH GUIDE
In Commercial Distribution

  • 03700111425040 ()
  • 03700111400047 ()

  • Outer Diameter: 0.16 Centimeter
  • Catheter Length: 26 Centimeter
1307000

  • Assisted reproduction transfer catheter trial

H-Pette with Blade (1000 pieces) - M52536120

No Description
HELENA LABORATORIES CORPORATION
3612
In Commercial Distribution

  • M52536120 ()


  • Blood/blood culture specimen transfer spike IVD, manual

Dialysate Sack (SAK) with Concentrate - M535SAK407A0

No Description
NXSTAGE MEDICAL, INC.
SAK-407-A
In Commercial Distribution

  • M535SAK407A5 ()
  • M535SAK407A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4070

No Description
NXSTAGE MEDICAL, INC.
SAK-407
In Commercial Distribution

  • M535SAK4075 ()
  • M535SAK4070 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK406A0

No Description
NXSTAGE MEDICAL, INC.
SAK-406-A
In Commercial Distribution

  • M535SAK406A5 ()
  • M535SAK406A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4060

No Description
NXSTAGE MEDICAL, INC.
SAK-406
In Commercial Distribution

  • M535SAK4065 ()
  • M535SAK4060 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK405A0

No Description
NXSTAGE MEDICAL, INC.
SAK-405-A
In Commercial Distribution

  • M535SAK405A5 ()
  • M535SAK405A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4050

No Description
NXSTAGE MEDICAL, INC.
SAK-405
In Commercial Distribution

  • M535SAK4055 ()
  • M535SAK4050 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK404A0

No Description
NXSTAGE MEDICAL, INC.
SAK-404-A
In Commercial Distribution

  • M535SAK404A5 ()
  • M535SAK404A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK403A0

No Description
NXSTAGE MEDICAL, INC.
SAK-403-A
In Commercial Distribution

  • M535SAK403A5 ()
  • M535SAK403A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK402A0

No Description
NXSTAGE MEDICAL, INC.
SAK-402-A
In Commercial Distribution

  • M535SAK402A5 ()
  • M535SAK402A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK401A0

No Description
NXSTAGE MEDICAL, INC.
SAK-401-A
In Commercial Distribution

  • M535SAK401A5 ()
  • M535SAK401A0 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK4010

No Description
NXSTAGE MEDICAL, INC.
SAK-401
In Commercial Distribution

  • M535SAK4015 ()
  • M535SAK4010 ()


  • Haemodialysis concentrate

Dialysate Sack (SAK) with Concentrate - M535SAK3070

No Description
NXSTAGE MEDICAL, INC.
SAK-307
In Commercial Distribution

  • M535SAK3075 ()
  • M535SAK3070 ()


  • Haemodialysis concentrate

PLEGIOX Heat Exchanger with Cardioplegia - 04037691180038

The PLEGIOX cardioplegia heat exchanger is used for adjusting the temperature of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The PLEGIOX contains heat exchanger fibers through which the cooling or heating fluid is pumped. The fluid to be temperature controlled flows around the outside of these fibers. Deairing is ensured by a bubble trap with a filter integrated in the upper part of the PLEGIOX. An integrated bypass stopcock enables hot-shot to be performed.
Maquet Cardiopulmonary AG
CHX 30, Non-coated, Sterile
Not in Commercial Distribution

  • 04037691180038 ()
  • 04058863052267 ()

  • Total Volume: 46.885 Liter
  • Weight: 0.35 Kilogram
70103.2522

  • Cardiopulmonary bypass system heat exchanger, reusable

Micro tube 0.5ml with cap - 04038917994484

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.309
In Commercial Distribution

  • 04038917994507 ()
  • 04038917994484 ()


  • Assay container IVD, single-use

Micro tube 0.5ml with cap - 04038917994316

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.307
In Commercial Distribution

  • 04038917994330 ()
  • 04038917994316 ()


  • Assay container IVD, single-use

Micro tube 0.5ml with cap - 04038917994026

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.300
In Commercial Distribution

  • 04038917994040 ()
  • 04038917994026 ()


  • Assay container IVD, single-use

Micro tube 1.5ml with cap - 04038917431149

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.703.207
In Commercial Distribution

  • 04038917431156 ()
  • 04038917431149 ()
72.703.207

  • Assay container IVD, single-use

Micro tube 0.5ml with cap - 04038917390804

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.730.407
In Commercial Distribution

  • 04038917390811 ()
  • 04038917390804 ()
72.730.407

  • Assay container IVD, single-use

Micro tube 2.0ml with cap - 04038917390774

No Description
Sarstedt Aktiengesellschaft & Co.KG
72.694.407
In Commercial Distribution

  • 04038917390781 ()
  • 04038917390774 ()
72.694.407

  • Assay container IVD, single-use

LOCATOR, compatible with Anthogyr System - 00840481127564

LOCATOR Extended Range Replacement Male (Orange) (4 Pack)
Zest Anchors, LLC
08915
In Commercial Distribution

  • 00840481127564 ()
08915-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127557

LOCATOR Zero Retention Extended Range Gray Male (4 pack)
Zest Anchors, LLC
08558
In Commercial Distribution

  • 00840481127557 ()
08558-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127540

LOCATOR Extended Range Replacement Male (red) (4 Pack)
Zest Anchors, LLC
08548
In Commercial Distribution

  • 00840481127540 ()
08548-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127533

LOCATOR Extended Range Replacement Male (Green) (4 Pack)
Zest Anchors, LLC
08547
In Commercial Distribution

  • 00840481127533 ()
08547-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127526

LOCATOR Extended Range Male Processing Package (2 Pack)
Zest Anchors, LLC
08540-2
In Commercial Distribution

  • 00840481127526 ()
08540-2-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127519

LOCATOR Female Analog (4.0mm) (4 Pack)
Zest Anchors, LLC
08530
In Commercial Distribution

  • 00840481127519 ()
08530-AN-SB

  • Dental implant analog

LOCATOR, compatible with Anthogyr System - 00840481127502

LOCATOR Extra Light Retention Male (Blue) (4 pack)
Zest Anchors, LLC
08529
In Commercial Distribution

  • 00840481127502 ()
08529-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127496

LOCATOR “Light Retention” Replacement Male (Pink) (4 Pack)
Zest Anchors, LLC
08527
In Commercial Distribution

  • 00840481127496 ()
08527-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127489

LOCATOR Replacement Male (Clear) (4 Pack)
Zest Anchors, LLC
08524
In Commercial Distribution

  • 00840481127489 ()
08524-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127472

LOCATOR Male Processing Package (2 Pack)
Zest Anchors, LLC
08519-2
In Commercial Distribution

  • 00840481127472 ()
08519-2-AN-SB

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Anthogyr System - 00840481127465

LOCATOR Impression Coping (4 Pack)
Zest Anchors, LLC
08505
In Commercial Distribution

  • 00840481127465 ()
08505-AN-SB

  • Dental implant analog

LOCATOR, compatible with Anthogyr System - 00840481127458

LOCATOR Core Tool
Zest Anchors, LLC
08393
In Commercial Distribution

  • 00840481127458 ()
08393-AN-SB

  • Dental soft-tissue coring punch, reusable

LOCATOR, compatible with Ankylos System - 00840481127298

LOCATOR Processing Spacer (4 Pack)
Zest Anchors, LLC
08569
In Commercial Distribution

  • 00840481127298 ()
08569-FD

  • Dental impression spacer

LOCATOR, compatible with Ankylos System - 00840481127281

LOCATOR Zero Retention Extended Range Gray Male(4 Pack)
Zest Anchors, LLC
08558
In Commercial Distribution

  • 00840481127281 ()
08558-FD

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Ankylos System - 00840481127274

LOCATOR Abutment Holder Sleeve (4 Pack)
Zest Anchors, LLC
08394
In Commercial Distribution

  • 00840481127274 ()
08394-FD

  • Dental soft-tissue coring punch, reusable

LOCATOR, compatible with Ankylos System - 00840481127267

LOCATOR Block Out Spacer (20 pack)
Zest Anchors, LLC
08514
In Commercial Distribution

  • 00840481127267 ()
08514-FD

  • Dental impression spacer

LOCATOR, compatible with Ankylos System - 00840481127250

LOCATOR Black Processing Replacement Male (4 pack)
Zest Anchors, LLC
08515
In Commercial Distribution

  • 00840481127250 ()
08515-FD

  • Dental implant suprastructure, permanent, preformed

LOCATOR, compatible with Ankylos System - 00840481127243

LOCATOR Female Analog (5.0mm) (4Pack)
Zest Anchors, LLC
08516
In Commercial Distribution

  • 00840481127243 ()
08516-FD

  • Dental implant analog

LOCATOR, compatible with Ankylos System - 00840481127236

LOCATOR Female Analog (4.0mm)(4 Pack)
Zest Anchors, LLC
08530
In Commercial Distribution

  • 00840481127236 ()
08530-FD

  • Dental implant analog

LOCATOR, compatible with Ankylos System - 00840481127229

LOCATOR Impression Coping (4 Pack)
Zest Anchors, LLC
08505
In Commercial Distribution

  • 00840481127229 ()
08505-FD

  • Dental implant analog

LOCATOR, compatible with Ankylos System - 00840481127212

LOCATOR "Extra Light Retention" Extended Range Replacement Male (Red) (4 Pack)
Zest Anchors, LLC
08548
In Commercial Distribution

  • 00840481127212 ()
08548-FD

  • Dental implant suprastructure, permanent, preformed
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